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FDA Finalizes New Final Guidance on Facility Readiness and Goal Dates
The FDA received no comments on the draft guidance titled Facility Readiness: Goal Date Decisions Under GDUFA, and, as such, has finalized the guidance with only minor editorial changes. The advance prepublication of the Federal Register Notice (here) notes, “[U]nder the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under […]